Clinical Quality Assurance Associate (m/f)

Our client, a pharmaceutical company in Munich, is currently looking for a



Clinical Quality Assurance Associate (m/f)

Activities and responsibilities

  • Proactively support / collaborate with key stakeholders to ensure that risks are identified, regularly reviewed, communicated and controlled
  • Support deviation/incident management for deviations pertinent to the programs being assigned and collaborate with other QA teams and business to drive continuous improvement
  • Provide regulatory intelligence guidance to questions arising from Clinical trials deliverables
  • Participate in review and approval of key Clinical Study documents (e.g. Study Protocols, Monitoring Plans and Clinical Study Reports)
  • Collaborate with other QA functions and business to drive outsourced activities
  • Support inspection management (preparation, hosting, follow-up) in collaboration with other QA groups and business functions
  • Support audit planning, management and follow-up

Qualification profile

  • B.Sc. in Life Sciences, Pharmacy or Medicines with at least 6 years of experience in regulated activities (GCP/PV), clinical development and/or quality assurance positions or similar background
  • Broad understanding of global expectations of Health Authorities regarding Clinical Development and profound understanding of product development
  • Two or more years of experience in project management
  • Ability to effectively interact with and present to senior management, as well as to external audiences and inspectors
  • Experience in Late Phase Clinical Development desirable
  • Auditing Experience desirable
  • Strong interpersonal, communication, negotiation and problem solving skills
  • Ability to work independently and in a global environment

Benefits

  • Fascinating employer
  • Access to non- published job offers
  • Active presentation of your qualifications to our client
  • Advise on your application from our recruitment specialists
  • Representation and Protection of your interest

Send application to

Deborah Angelè
Kelly Services München
T: 089 3840907
M: deborah.angele[at]kellyservices.de

While applying for the job please refer to jobvector

About Kelly Scientific Resources München

Unsere Berater und Manager im Fachbereich Kelly Scientific Resources - alle ebenfalls ausgebildete Naturwissenschaftler mit langjähriger Berufserfahrung - widmen sich mit ihrer Fachkenntnis ausschließlich der Identifizierung, Beratung und Vermittlung von naturwissenschaftlichem und medizinischem Fach- und Führungspersonal in einem breiten Spektrum von Branchen und Berufsfeldern. Wir erkennen...

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